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Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer

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ClinicalTrials.gov Identifier: NCT02570815
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Toronto General Hospital
Information provided by (Responsible Party):
Wael Hanna, St. Joseph's Healthcare Hamilton

Brief Summary:

Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.

With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.

Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: indocyanine green Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer: Analysis of Accuracy and Added Value
Study Start Date : October 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: indocyanine green
Non-toxic, fluorescent dye
Drug: indocyanine green
ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.
Other Name: IC-GREEN




Primary Outcome Measures :
  1. Feasibility of using NIF-guidance in robotic pulmonary segmentectomy for early-stage lung cancer will be evaluated using items 1, 2, and 3 of a 7-item binary rating scale. An score of 3/7 for these items will indicate success. [ Time Frame: 1 year ]
    Item 1: Visualization of fluoresced lung by NIF imaging; Item 2:Demarcation of a dark segment and inter-segmental plane; Item 3: Completion of segmental resection along the borders of the dark-segmental plane.


Secondary Outcome Measures :
  1. Safety will be measured by the rate of adverse reactions to ICG dye as defined by the Ottawa Thoracic Morbidity and Mortality classification [ Time Frame: 1 year ]
  2. Safety will also be measured by the rate of perioperative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification [ Time Frame: 1 year ]
  3. Anatomical accuracy will be evaluated using items 4, 5, and 6 of the Indocyanine Green Segmentectomy 7-Item Binary Scale. A score of 3/7 on these items will indicate success of anatomical accuracy [ Time Frame: 1 year ]
    Item 4: Ex-vivo localization of lesions; Item 5: Ex-vivo confirmation of tumor-free margins around lesion; Item 6: Ex-vivo confirmation of adequate anatomical inter-segmental.

  4. Added value of ICG-guidance will be evaluated using Item 7 of the 7-item binary rating scale. A score of 1/7 will indicate added value of ICG-guidance [ Time Frame: 1 year ]
    Item 7: Added value of NIF-guidance

  5. Overall success of the intervention will be evaluated using Items 1-7 of the binary rating scale, only an aggregate score of 7/7 will be considered a success [ Time Frame: 1 year ]
  6. Reproducibility and validity of the procedure will be measured by the rate of overall success [ Time Frame: 1 year ]
  7. Partial success of the intervention will be measured by scores between 1/5 and 4/5 on the 7-item binary scale [ Time Frame: 1 year ]
  8. Length of time of the procedure will be measured by collecting the procedure start and procedure start time [ Time Frame: 1 year ]
  9. Length of time of the operation will be measured by collecting the time the patient entered the operating room until the time the patient left the operating room [ Time Frame: 1 year ]
  10. Rate of conversions to lobectomy will be measured by collecting the proportion of conversions to lobectomy or thoracotomy [ Time Frame: 1 year ]
  11. Rate of conversion to thoracotomy will be measured by collecting the proportion of conversions to thoracotomy [ Time Frame: 1 year ]
  12. Duration the patient had chest tubes in situ will be measured by collecting the date of surgery and the date the chest tube was removed [ Time Frame: 1 year ]
  13. Duration of hospital length of stay will be measured by collecting the data of admission and the date of discharge [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Tumor size <3 cm
  3. Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
  4. CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.

Exclusion Criteria:

  1. Hypersensitivity or allergy to ICG, sodium iodide or iodine
  2. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570815


Contacts
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Contact: Lisa L Patterson, BA 905-522-1155 patterls@stjoes.ca
Contact: Christine Fahim, PhD(c) 905-522-1155 tfahim@stjosham.on.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Lisa Patterson    905-522-1155 ext 35096    pattersl@stjoes.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Toronto General Hospital
Investigators
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Principal Investigator: Waël C. Hanna, MDCM, MBA, FRCSC St. Joseph's Healthcare Hamilton / McMaster University

Publications:
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Responsible Party: Wael Hanna, Director, Research Program, Boris Family Centre for Robotic Surgery, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02570815     History of Changes
Other Study ID Numbers: BFCRS-RP-001-1504-29
101 ( Other Identifier: Hamilton Integrated Research Ethics Board )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wael Hanna, St. Joseph's Healthcare Hamilton:
lung cancer
segmentectomy
robotic surgery
near-infrared fluorescent
IC-GREEN
indocyanine green
early-stage lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases